Stability Indicating Analytical method development & Validation of 2, 4 - dihydroxy-5- Fluoro Pyrimidine in bulk drugs & its Injection formulation
DOI:
https://doi.org/10.61096/ijpar.v5.iss4.2016.650-657Abstract
Stability indicating HPLC method is developed for 2,4-dihydroxy-5-fluoropyrimidine bulk drug and its formulation, all validation parameters including specificity (interference, forced degradation), Precision (system, method, intermediate), Linearity, accuracy, range ,robustness studied, forced degradation (acid, base, peroxide, water, thermal ,humidity, photo stability effect studied for 2,4-dihydroxy-5-fluoropyrimidine,Retention time was found to be 3.4minutes at the wave length of 254nm.